Nanotechnology Overview

Nanotechnology is an emerging technology that has the potential for use in a broad array of FDA-regulated products, including medical products, foods and cosmetics. Nanomaterials, developed using nanotechnology, are measured in nanometers — equal to about one-billionth of a meter — so small that they cannot be seen with a regular microscope. These nanomaterials can have different chemical, physical, or biological properties than their conventionally-scaled counterpart materials used in many products regulated by FDA.

FDA has long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies. Nanotechnology is not unique in this regard. The very changes in biological, chemical and other properties that can make nanotechnology applications so exciting also may merit examination to determine any effects on product safety, effectiveness, or other attributes. Understanding nanotechnology remains a top FDA priority. FDA is monitoring the evolving science and has a robust research agenda to help assess the safety and effectiveness of products using nanotechnology.

Strong science is critical to FDA’s ongoing review of the products it regulates. FDA is investing in a nanotechnology regulatory science program to further enhance FDA’s scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products. In general, the agency considers the current framework for safety assessments sufficiently robust and flexible to be appropriate for a variety of materials, including nanomaterials.

FDA is maintaining a product-focused and science-based regulatory policy to appropriately regulate products using this emerging technology. Legal standards vary among various product-categories that FDA regulates. FDA will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. The Agency is taking a prudent scientific approach to assess each product on its own merits, and does not make broad, general assumptions about the safety of nanotechnology products.

FDA’s Action on Nanotechnology

In June 2011, FDA issued a Draft Guidance for Industry entitled, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" to present its thinking on considerations related to nanotechnology. In that draft guidance, FDA indicated that the Agency would issue product-specific guidance documents in the future, as appropriate.

In April 2012, FDA issued two product-specific draft guidances for public comment, addressing the use of nanotechnology by the foods and cosmetics industries.

After considering the public comments, FDA finalized all three guidance documents. FDA also issued a draft guidance on the use of nanomaterials in food for animals. They are:

Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

This guidance provides an overarching framework for FDA’s approach to the regulation of nanotechnology products. It identifies two points to consider when determining whether the FDA-regulated product involves the application of nanotechnology. An affirmative finding to either of the points to consider might suggest the need for particular attention by the Agency and/or industry to the product to identify and address potential implications for safety, effectiveness, public health impact, or regulatory status of the product.

The points to consider are intended to be a broad screening tool for FDA purposes, reflecting the fact that for purposes of ensuring that all applicable requirements are met, FDA’s interest extends to the properties exhibited by products that involve the use of nanotechnology, and does not focus on size alone. FDA may further refine these points to consider as the science evolves. The guidance does not establish a regulatory definition of the term "nanotechnology" or any related vocabulary.

The final guidance also encourages industry to consult with the FDA early in the product development process to address questions related to the safety, effectiveness, or other attributes of nanotechnology products, or to address questions about regulatory status of the products.

Final Guidance for Industry: Safety of Nanomaterials in Cosmetic Products

This guidance describes FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products.

Cosmetics and cosmetic ingredients (with the exception of color additives) are not subject to premarket approval; however, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled.

Cosmetics manufactured using nanomaterials are subject to the same legal requirements as any other cosmetics. Companies and individuals who market cosmetics are legally responsible for the safety of their products.

In general, the framework currently in use for assessing safety of cosmetics is appropriate for cosmetics containing nanomaterials. However, data needs and testing methods should be evaluated in light of the properties, behaviors, and/or effects that may be exhibited by nanomaterials used in cosmetic products.

Final Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives

This guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including those involving nanotechnology, on the safety and regulatory status of food substances. This guidance describes the factors manufacturers should consider when determining whether a significant change in manufacturing process for a food substance already in the market:

Affects the identity of the food substance;

Affects the safety of the use of the food substance;

Affects the regulatory status of the use of the food substance; and

Warrants a regulatory submission to FDA.

The final foods guidance also recommends manufacturers consult with FDA regarding a significant change in manufacturing process for a food substance already in the market.

Draft Guidance for Industry: Use of Nanomaterials in Food for Animals

This draft guidance describes FDA’s current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. This draft guidance addresses the legal framework for adding substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient. FDA’s draft recommendations for developing an FAP for a nanomaterial animal food ingredient highlight considerations for the following sections of an FAP:

Identity;

Manufacturing Methods and Controls;

Intended Use, Use Level, and Labeling;

Analytical Methods;

Safety Evaluation and Proposed Tolerances for the Food Additive;

Proposed Regulation; and

Environmental Assessment.

This draft guidance also recommends manufacturers consult with FDA early in the development of their nanomaterial animal food ingredient and before submitting an FAP.

FDA’s Approach to Regulation of Nanotechnology Products

FDA will continue to regulate nanotechnology products under its existing statutory and regulatory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. FDA intends to ensure transparent and predictable regulatory pathways grounded in the best available science.

FDA does not make a categorical judgment that nanotechnology is inherently safe or harmful. We intend our regulatory approach to be adaptive and flexible and to take into consideration the specific characteristics and the effects of nanomaterials in the particular biological context of each product and its intended use.

Particular approaches for each product area will vary according to the statutory authorities. The scope and issues covered in the product-specific guidance documents reflect this approach.

FDA’s nanotechnology regulatory science research portfolio focuses on understanding interactions of nanomaterials with biological systems; and on the adequacy of testing approaches for assessing safety, effectiveness, and quality of products containing nanomaterials.

FDA’s regulatory policy approach is consistent with relevant overarching U.S. government policy principles, and supports innovation under appropriate oversight.

Industry remains responsible for ensuring that its products meet all applicable legal requirements, including standards for safety — regardless of the emerging nature of a technology involved in the manufacturing of a product. FDA encourages industry to consult with the Agency early in the product development process to address any questions related to the safety, effectiveness, or other attributes of products that contain nanomaterials, or about the regulatory status of such products. Early consultations with FDA facilitate a mutual understanding of the specific scientific and regulatory issues for nanotechnology products.

Comments on the Draft Food for Animals Guidance Document

Although anyone may comment on any guidance at any time, in order to ensure that FDA considers comments on the document, "Draft Guidance for Industry: Use of Nanomaterials in Food for Animals" in developing the final guidance on this topic, electronic or written comments on this draft guidance should be submitted within 75 days of the publication of the notice of availability in the Federal Register. Electronic comments should be submitted to http://www.regulations.gov/. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.